ORLANDO, Fla., June 26 /PRNewswire/ — Data from four
pivotal Phase III clinical trials demonstrate that linagliptin
achieved statistically significant and sustained reductions in
blood sugar as measured by hemoglobin A1c (HbA1c),(1-4) fasting
plasma glucose (FPG)(1-4) and postprandial glucose (PPG).(1,2)
Boehringer Ingelheim Pharmaceuticals, Inc. is investigating
the dipeptidyl peptidase 4 (DPP-4) inhibitor as an oral once-daily
tablet, as monotherapy and combination therapy, to treat type 2
diabetes. The linagliptin data are being presented this week at the
70th Annual American Diabetes Association (ADA) Scientific Sessions
in Orlando, Fla.
In the Phase III studies, statistically significant
placebo-adjusted changes in HbA1c were observed with linagliptin (5
mg) monotherapy versus placebo (-0.69 percent, p<0.0001)(1) and
when used in combination with other commonly-used oral
anti-diabetic drugs, including metformin (-0.64 percent,
p<0.0001),(2) metformin plus a sulfonylurea (-0.62 percent,
p<0.0001),(3) and as initial combination with pioglitazone
(-0.51 percent, p<0.0001).(4) Linagliptin therapy also resulted
in improvements in beta-cell function.(1) Declining beta-cell
function is believed to be a key factor driving the progression of
type 2 diabetes.(5)
“It is imperative that blood sugar levels in people with type 2
diabetes are adequately controlled,” said Dr. Giora Davidai, executive director &
medical leader, medical affairs, cardiovascular & metabolic
medicine, Boehringer Ingelheim Pharmaceuticals, Inc. “Uncontrolled
blood sugar puts type 2 diabetes patients at a higher risk of
developing serious complications like renal impairment and
cardiovascular disease, which are very common in patients with type
2 diabetes.”
‘/>”/>